HMP · Pad, Eye
General, Plastic Surgery · 21 CFR 878.4440 · Class 1
Overview
| Product Code | HMP |
|---|---|
| Device Name | Pad, Eye |
| Regulation | 21 CFR 878.4440 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K940333 | EYE PAD | Certified Safety Mfg., Inc. | Mar 7, 1994 | SESE |
| K921349 | STERILE,DISPOSABLE EYE DRESSING | Deroyal Industries, Inc. | May 29, 1992 | SESE |
| K904896 | EYE PAD | Ulti-Med Intl., Inc. | Dec 5, 1990 | SESE |
| K883822 | FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 | Consolidated Industries of Greater Syracuse, Inc. | Nov 22, 1988 | SESD |
| K874411 | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' | Keeler Instruments, Inc. | Jan 27, 1988 | SESE |
| K864810 | LIDSPLINT | Precision Therapeutics, Inc. | Jan 20, 1987 | SESE |
| K861456 | SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR | Pantheon Products, Inc. | Jul 25, 1986 | SN |
| K860979 | DONALDSON NATURAL EYEPATCH | Keeler Instruments, Inc. | Apr 4, 1986 | SESE |
| K851906 | SURGICAL EYE PACK | Xanmed Corp. | May 21, 1985 | SESE |
| K850099 | VISOPROTECT: OCCULAR SHIELD | Rockway Enterprises, Inc. | Mar 20, 1985 | SESE |
| K850005 | VISOPROTECT OCCULAR SHIELD | M.S.G. Health Systems, Inc. | Mar 20, 1985 | SESE |
| K843197 | VISITEC EYE SHIELD | Visitec Co. | Oct 5, 1984 | SESE |
| K803145 | CONPHAR EYE PROTECTOR | Conphar, Inc. | Feb 5, 1981 | SESE |
| K802799 | EYE PADS | Secol Co. | Dec 17, 1980 | SESE |
| K801995 | EYE PADS CAT.#581-599 | Pollak (Intl.), Ltd. | Sep 9, 1980 | SESE |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Medi-Spec | Apr 24, 1980 | SESE |
| K781539 | ISO-CARE KIT | Nice-Pak Products, Inc. | Nov 3, 1978 | SESE |
Top Applicants
- Keeler Instruments, Inc. — 2 clearances
- Xanmed Corp. — 1 clearance
- Visitec Co. — 1 clearance
- Ulti-Med Intl., Inc. — 1 clearance
- Secol Co. — 1 clearance
